SPK helps this global enterprise to boost product development efficiencies, increase compliance reliability, generate reports with a single click, and shave weeks off their development/release cycles. The Client A respected global medical device powerhouse, with more...
Compliance & Regulatory
How AWS Cloud Solutions Can Help Your Manufacturing Enterprise Maintain Its Competitive Edge
Executive Summary In 2020, public and private cloud-based solutions like Amazon Web Services surpassed traditional data centers in terms of overall spending. In 2017, nearly two thirds of spending went toward private cloud solutions. Cloud usage exploded in 2017, to...
How Hybrid Cloud Can Turbo Charge Your Manufacturing Enterprise
Executive Summary That’s the year public and private cloud-based solutions are set to surpass traditional data centers in terms of overall spending. In 2017, nearly two thirds of spending went toward private cloud solutions. Cloud usage exploded in 2017, to the tune...
Continuous Delivery pipeline with CloudBees CD for major insurance carrier
The ClientFounded in the early 1900’s, this major insurance provider administers health benefits to more than 4 million individuals. Because of the types of services this client provides to its customers, they are heavily reliant upon software technology and technical...
The Power of the Cloud – Med Device Company Boosts Operational Efficiency and Customer Satisfaction
BackgroundA diversified medical device company has a leading position in the global endoscopy device space. In this market, the company generates growth and differentiates its products primarily through incremental innovations and investment in research and...
Leading Medical Device Company Achieves Major Efficiency Boost by Utilizing SPK’s SolidWorks CSV Expertise
Background Apublicly traded medical device manufacturer with 33,000 employees and several international locations approached SPK and Associates for assistance in streamlining their validation processes. The validation process took months, but the customer wanted...
Problems that Engineers in Regulated Industries Face
https://www.youtube.com/watch?v=Og6826J7EOo Video Transcript: I'm Carlos Almeida, VP of Engineering at SPK and Associates. I've spent most of my professional life doing software engineering. 25 years plus in the world of high tech in the electronic design automation...
Test Management in Windchill RV&S (PTC Integrity)
The importance of test management, especially in highly-regulated industries, cannot be overstated. Efficient management of testing requirements leads to safer products, effective production, and satisfied customers. The PTC Windchill Requirements Validation &...
Risk Management in Windchill RV&S (formerly PTC Integrity Lifecycle Manager)
An important part of creating any product intended for use in any regulated industry vertical is that the manufacturer should have identified all of the risks involved in using the device. Then, they must have done their best to mitigate those risks before their...
What’s in the MITRE/FDA Playbook?
On October 2018, the MITRE Corporation and the Food and Drug Administration released their joint document, Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. This is the new Bible for organizations designing and manufacturing connected...
How Cyber Security Requirements Can Throw your Medical Device Off Track
In our last article we talked about the four steps your organization must go through when designing secure connected medical devices. With the increasing attention paid to product security in this era of connected medical devices, many companies are scrambling to keep...
Top 3 PLM Predictions from Oleg Shilovitsky — Talking Beyond PLM
SPK and Associates co-founder Chris McHale spoke with PLM expert Oleg Shilovitsky, founder of BeyondPLM.com, to get his top three product lifecycle management (PLM) predictions for 2015. PLM vendors will encounter greater complexity when delivering cloud solutions New...